Endologix Receives CE Mark Approval For Expanded Line Of Powerlink Products And PowerFit Aortic Extensions

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 28 Aug 2010 - 1:00 PDT

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Endologix, Inc. (Nasdaq: ELGX), developer of minimally invasive treatments for aortic disorders, announced that it received CE Mark approval to market its expanded offering of Powerlink® stent graft products and PowerFit™ Aortic Extensions in the European Union. The Company expects to launch the products in a limited market release in Europe during the fourth quarter of 2010, followed by a full product launch in 2011. Endologix recently received U.S. Food and Drug Administration (FDA) approval for these new products and they are currently in a limited market release in the U.S., with a full market release in the U.S. planned for the fourth quarter of 2010.

John McDermott, President and Chief Executive Officer of Endologix, said, "We are excited to begin rolling out our expanded product portfolio following its limited market release in the United States during the third quarter. We have received extremely positive feedback from U.S. physicians on the new sizes and PowerFit, which gives us confidence that these new devices will be well received in the European market. The new sizes of Powerlink stent grafts are allowing physicians to treat a wider group of patients, including those with short iliac arteries. Physicians are also benefitting from the improved visibility, conformability and sealing achieved with the PowerFit Aortic Extensions. All together, we now have a comprehensive AAA product offering that will allow us to gain additional market share in the U.S. and Europe as physicians are able to utilize anatomical fixation for more of their AAA patients."

The CE Mark approval covers 31 new sizes of Powerlink main body bifurcated, proximal extension, and limb extension stent grafts that increase the system's addressable patient population by 5% to 10%. It also covers PowerFit Aortic Extensions, which are available in a range of sizes indicated to treat aortic necks ranging from 18 to 32 millimeters in diameter. In addition, the PowerFit product line is available with longer stent lengths of up to 120 millimeters, to expand the treatment options for physicians and their patients.

Forward-Looking Statements

Except for historical information contained herein, this news release contains forward-looking statements, the accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix. Many factors may cause actual results to differ materially from anticipated results, including the success of sales efforts for the Powerlink System and related new products, product research and development efforts, and other economic, business, competitive and regulatory factors. The Company undertakes no obligation to update its forward looking statements. Please refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2009, and the Company's other filings with the Securities and Exchange Commission, for more detailed information regarding these risks and other factors that may cause actual results to differ materially from those expressed or implied.

Source: Endologix, Inc

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